Tissue-removing catheter including force-transmitting member for actuating a cutter housing

ABSTRACT

A tissue-removing catheter includes a cutter. The catheter also includes a longitudinal force-transmitting member extending along a catheter body and being longitudinally movable relative to the catheter body. A distal end portion of the longitudinal force-transmitting member is operatively connected to a distal longitudinal portion of a cutter housing such that distal movement of the longitudinal force-transmitting member relative to the catheter body and the cutter imparts pivoting of the distal longitudinal portion to its open position to expose the cutter.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent Ser. No.14/101,958, filed Dec. 10, 2013, now U.S. Pat. No. 9,636,138, whichclaims priority to U.S. Provisional Application Ser. No. 61/736,182,filed Dec. 12, 2012, the entirety of each of which is herebyincorporated by reference.

FIELD OF THE DISCLOSURE

The present invention generally relates to a tissue-removing catheterfor removing tissue from a body lumen including a force-transmittingmember for actuating a cutter housing.

BACKGROUND OF THE DISCLOSURE

Vascular disease frequently arises from the accumulation of atheromatousmaterial on the inner walls of vascular lumens, particularly arteriallumens of the peripheral and other vasculature, especially peripheralarteries, resulting in a condition known as atherosclerosis.Atherosclerosis occurs naturally as a result of aging but may also beaggravated by factors such as diet, hypertension, heredity, vascularinjury, and the like. Atheromatous deposits can have widely varyingproperties, with some deposits being relatively soft and others beingfibrous and/or calcified. In the latter case, the deposits arefrequently referred to as plaque.

Vascular disease can be treated in a variety of ways, including drugs,bypass surgery, and a variety of catheter-based approaches, includingthose which rely on intravascular debulking or removal of theatheromatous or other material occluding a blood vessel. A variety ofmethods for cutting or dislodging material and removing such materialfrom the blood vessel have been proposed, generally being referred to asatherectomy procedures. Atherectomy catheters intended to cut or excisematerial from the blood vessel lumen may employ a rotatable cuttingblade (or other tissue-removing element) which can be advanced into orpast the occlusive material in order to cut and separate such materialfrom the blood vessel lumen.

It is desirous to provide catheters which can access small, tortuousregions of body lumens and which can remove tissue and/or otheroccluding materials from within body lumens in a controlled fashion. Inone instance, it may be desired to provide atherectomy catheters whichcan facilitate capturing atheromatous materials. The catheters andmethods for use in a variety of body lumens, including but not limitedto coronary, peripheral, and other arteries, and other body lumens.

SUMMARY OF THE DISCLOSURE

The present disclosure is directed to a tissue-removing catheterincluding a cutter. In one aspect, the catheter includes a longitudinalforce-transmitting member extending along a catheter body and beinglongitudinally movable relative to the catheter body. A distal endportion of the longitudinal force-transmitting member is operativelyconnected to a distal longitudinal portion of a cutter housing such thatdistal movement of the longitudinal force-transmitting member relativeto the catheter body and the cutter imparts pivoting of the distallongitudinal portion to its open position to expose the cutting edge ofthe cutter.

In another aspect, the catheter includes a torque-transmitting memberextending along the catheter body and being rotatable relative to thecatheter body. A distal end portion of the torque-transmitting member isoperatively connected to the distal longitudinal portion of the cutterhousing such that rotation of the torque-transmitting member about alongitudinal axis relative to the catheter body and the cutter impartsrotation of the distal longitudinal portion to its open position toexpose the cutting edge of the cutter.

In yet another aspect, the catheter includes an expandable memberconnected to the cutter housing. The expandable member is configuredsuch that selective expansion of the expandable member from a contractedstate to an expanded state imparts pivoting of the distal longitudinalportion of the cutter housing about a hinge axis to its closed position.

In another aspect, the catheter includes an electrical conductorelectrically connected to the hinge portion and extending along thecatheter body. The electrical conductor is configured to supplyelectrical current from a power source to the hinge portion to heat thehinge portion, wherein heating of the hinge portion activatesheat-activating, shape-memory material and imparts pivoting of thedistal longitudinal portion about a hinge axis to one of the open andclosed positions.

Yet another aspect is directed to a tissue director of the catheter thatis distal of the cutter and configured to direct tissue removed by thecutter proximally through an axial cavity of the cutter.

Other features will be in part apparent and in part pointed outhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary perspective of a first embodiment of atissue-removing catheter;

FIG. 2 is an enlarged exploded perspective of distal end portion of thetissue-removing catheter, with a polymer jacket removed;

FIG. 3 is a longitudinal section of the distal end portion of thetissue-removing catheter;

FIG. 4 is an enlarged side elevation of the distal end portion of thetissue-removing catheter, with the cutter of the tissue-removingcatheter in a deployed, cutting position;

FIG. 5 is a longitudinal section of the distal end portion of thetissue-removing catheter of FIG. 4;

FIG. 6 is an enlarged, front elevation of a cutter of thetissue-removing catheter;

FIG. 7 is an enlarged, longitudinal section of the cutter of FIG. 6;

FIG. 8 is an enlarged perspective of a cutter housing of thetissue-removing catheter, the cutter housing being in a closed position;

FIG. 9 is a side elevational view of the cutter housing of FIG. 8;

FIG. 10 is a bottom plan view of the cutter housing of FIG. 8;

FIG. 11 is similar to FIG. 8, but with the cutter housing in an openposition;

FIG. 12 is a side elevation of the cutter housing of FIG. 11;

FIG. 13 is an enlarged longitudinal section of a distal portion of asecond embodiment of a tissue-removing catheter, a cutter housing of thecatheter being in a closed position;

FIG. 14 is similar to FIG. 13, but with the cutter housing being in anopen position;

FIG. 15 is an enlarged perspective of the cutter housing;

FIG. 16 is a side elevational view of the cutter housing of FIG. 15;

FIG. 17 is a bottom plan view of the cutter housing of FIG. 15;

FIG. 18 is a longitudinal section of the cutter housing of FIG. 15;

FIG. 19 is a side elevational view of a distal end portion of a thirdembodiment of a tissue-removing catheter, with a cutter housing of thecatheter being in an open position, and the cutter housing and thecutter driveshaft being partially transparent;

FIG. 20 is similar to FIG. 19, but with the cutter housing in a closedposition;

FIG. 21 is a side elevational view of a distal end portion of a fourthembodiment of a tissue-removing catheter, with a cutter housing of thecatheter being in an closed position, and the cutter housing and thecutter driveshaft being partially transparent;

FIG. 22 is similar to FIG. 21, but with the cutter housing in an openposition;

FIG. 23 is a fragmentary perspective of a fifth embodiment of atissue-removing catheter, including a removable handle attachable to aproximal end of the catheter;

FIG. 24 is an enlarged exploded view of a distal end portion of thetissue-removing catheter of FIG. 23;

FIG. 25 is an enlarged longitudinal section of the distal end portion ofthe tissue-removing catheter of FIG. 23, including a cutter housing ofthe catheter in a closed position;

FIG. 26 is similar to FIG. 25, but with a cutter housing of the catheterin an open position;

FIG. 27 is an enlarged, side elevation of a distal end portion of thetissue-removing catheter, the cutter housing being in the closedposition;

FIG. 28 is similar to FIG. 27, but with the cutter housing in the openposition;

FIG. 29 is an exploded perspective view of the tissue-removing catheterof the fifth embodiment, but further including a tissue director;

FIG. 30 is an enlarged longitudinal section of the distal end portion ofthe tissue-removing catheter of FIG. 29, including a cutter housing inan open position;

FIG. 31 is an enlarged perspective of the tissue director;

FIG. 32 is an enlarged left side elevational view of the tissuedirector;

FIG. 33 is a perspective view of the tissue-removing catheter of FIG.29, with the cutter housing removed;

FIG. 34 is an enlarged longitudinal section of a distal end portion ofof the tissue-removing catheter of the fifth embodiment, but furtherincluding another example of a tissue director, the cutter housing beingin a closed position;

FIG. 35 is similar to FIG. 34, but with the cutter housing being in anopen position;

FIG. 36 is a fragmentary perspective of a sixth embodiment of atissue-removing catheter, including a removable handle attachable to aproximal end of the catheter;

FIG. 37 is an exploded view of the tissue-removing catheter of FIG. 36;

FIG. 38 is an enlarged, side elevation of a distal end portion of thetissue-removing catheter of FIG. 36, the cutter housing being in theclosed position;

FIG. 39 is a longitudinal section of the catheter of FIG. 38;

FIG. 40 is similar to FIG. 38, but with the cutter housing in the openposition;

FIG. 41 is a longitudinal section of the catheter of FIG. 40;

FIG. 42 is an exploded perspective view of the tissue-removing catheterof the sixth embodiment, but further including a tissue director;

FIG. 43 is an enlarged longitudinal section of the distal end portion ofthe tissue-removing catheter of FIG. 42, including a cutter housing inan open position;

FIG. 44 is an enlarged right perspective of the tissue director; and

FIG. 45 is an enlarged left side perspective of the tissue director.

Corresponding reference characters indicate corresponding partsthroughout the drawings.

FIG. 46 is a fragmentary perspective of a seventh embodiment of atissue-removing catheter, including a removable handle attachable to aproximal end of the catheter;

FIG. 47 is an exploded view of a distal end portion the tissue-removingcatheter of FIG. 46;

FIG. 48 is an enlarged, side elevational view of a distal end portion ofthe tissue-removing catheter, the cutter housing being in the closedposition;

FIG. 49 is a longitudinal section of the catheter of FIG. 48;

FIG. 50 is similar to FIG. 48, but with the cutter housing in the openposition;

FIG. 51 is a longitudinal section of the catheter of FIG. 50;

FIG. 52 is a front perspective of the catheter of FIG. 50, with thecutter housing being rotated from the closed position to the openposition;

FIG. 53 is similar to FIG. 52, with the cutter housing in the openposition;

FIG. 54 is an enlarged perspective of a cutter of the tissue-removingcatheter of FIGS. 1-13; and

FIG. 55 is a front elevational view of the cutter of FIG. 54.

Corresponding reference characters indicate corresponding partsthroughout the drawings.

DETAILED DESCRIPTION OF THE DRAWINGS

Referring now to the drawings, several embodiments of a tissue-removingcatheter for removing tissue from a body lumen are disclosed. Inparticular, the illustrated catheter embodiments are suitable forremoving tissue from a body lumen, and are particularly suitable forremoving (i.e., excising) plaque tissue from a blood vessel (e.g.,peripheral arterial or peripheral venous wall). Features of thedisclosed embodiments, however, may also be suitable for treatingchronic total occlusion (CTO) of blood vessels, particularly peripheralarteries, and stenoses of other body lumens and other hyperplastic andneoplastic conditions in other body lumens, such as the ureter, thebillary duct, respiratory passages, the pancreatic duct, the lymphaticduct, and the like. Neoplastic cell growth will often occur as a resultof a tumor surrounding and intruding into a body lumen. Removal of suchmaterial can thus be beneficial to maintain patency of the body lumen.While the remaining discussion is directed toward catheters for removingtissue from and penetrating occlusions in blood vessels (e.g.,atheromatous or thrombotic occlusive material in an artery, or otherocclusions in veins), it will be appreciated that the teachings of thepresent disclosure apply equally to other types of tissue-removingcatheters, including, but not limited to, catheters for penetratingand/or removing tissue from a variety of occlusive, stenotic, orhyperplastic material in a variety of body lumens.

Referring now to FIGS. 1-12, a first embodiment of a tissue-removingcatheter for removing tissue from a body lumen is generally indicated at110. Briefly, the tissue-removing catheter 110 includes an elongatetubular catheter body 112 having opposite proximal and distal ends, acentral longitudinal axis LA₂(FIG. 4) extending between the distal andproximal ends. A rotatable cutter, generally indicated at 116, isoperatively connected adjacent the distal end of the catheter body 112for removing tissue from body lumen. In particular, in the illustratedembodiment the cutter 116 is operatively connected to a cutter housinggenerally indicated at 118, which is received in the catheter body 112and forms part of a deployment mechanism, generally indicated at 124, asexplained below. The catheter 110 also includes a hollow cutterdriveshaft 120 (FIGS. 3 and 5), which drives rotation of the cutter 116,and a separate screw conveyor, generally indicated at 122 (also known asan auger conveyor), which transports or moves removed tissue proximallywithin the catheter body 112. The cutter driveshaft 120 defines aninternal, tissue-transport passage 123 through which a screw blade 125(or flighting) of the screw conveyor extends and through which theremoved tissue is transported proximally.

Referring still to FIG. 1, the catheter body 112 is configured (e.g.,sized and shaped) for intravascular introduction into the target artery,although as explained above, the catheter body may be configured forintraluminal introduction into other target body lumens other than atarget artery. The catheter body 112 includes an outer polymer jacket111 (e.g., an overmold) that is disposed along at least a longitudinalportion of the catheter 110. In the illustrated embodiment, the jacket111 defines a guidewire channel 111 a adjacent the distal end portion ofthe catheter body 112 that is configured for introduction of thecatheter body 112 over a guidewire to a target site within thevasculature. In particular, the catheter 110 is configured for “rapidexchange” introduction because the guidewire channel 111 a extends onlythrough a distal portion of the catheter body, although the catheter maybe configured for “over-the-wire” introduction where the guidewirechannel extends fully through the catheter body 112. In other cases, itmay be possible to provide a fixed or integral coil tip or guidewire tipon the distal portion of the catheter 110 or even dispense with theguidewire entirely. Moreover, a flexible distal tip (not shown) may besecured to the distal end of the illustrated catheter to facilitateinsertion of the catheter. For convenience of illustration, guidewireswill not be shown in any embodiment, but it should be appreciated thatthey can be incorporated into any of these embodiments.

The dimensions and other physical characteristics of the catheter body112 may vary depending on the artery (or other body lumen) of thesubject which is to be accessed. The catheter body 112 is generallyflexible and may in one embodiment have a length in the range from 50 cmto 200 cm and an outer diameter in the range from 1 French to 12 French(0.33 mm:1 French), such as from 3 French to 9 French. The catheter body112 (e.g., the jacket 111) may be composed of an organic polymer whichis fabricated by extrusion techniques. Suitable polymers, such as forthe jacket 111, include polyvinylchloride, polyurethanes, polyesters,polytetrafluoroethylenes (PTFE), silicone rubbers, natural rubbers, andthe like. Optionally, the catheter body 112 may be reinforced with abraid, helical wires, coils, axial filaments, or the like, in order toincrease rotational strength, column strength, toughness, pushability,and the like. For example, the catheter body 112 may include a torquetube, as is generally known in the art. The outer diameter of thecatheter body 112 can be modified by heat expansion and shrinkage usingconventional techniques. It will be appreciated that the constructionand dimensions of the catheter body may be other than described withoutdeparting from the scope of the present invention.

The catheter body 112 of the present embodiment may include an urgingmechanism (not shown) to urge the cutter into engagement with the bodylumen wall (e.g., blood vessel wall) during treatment. For example, theurging mechanism may comprise a portion of the catheter body adjacent toand proximal of the cutter that is biased to (e.g., permanently deformedin) a double-bent or double-curved shape to urge the cutter toward awall of a body lumen to enhance treatment. A suitable urging mechanismis disclosed in U.S. Pat. No. 7,708,749, the entirety of which is herebyincorporated by reference. In other embodiments, the urging mechanismmay take many other suitable forms. The catheter may have no urgingmechanism without departing from the scope of the present invention.

Referring to FIGS. 12 and 14, as set forth above, the catheter 110includes the rotatable cutter 116 and the driveshaft 120 for impartingrotation of the cutter. The driveshaft 120 extends along a longitudinalpassage 126 in the catheter body 112 such that the driveshaft isgenerally coaxial with the catheter body. As explained below, in theillustrated embodiment the driveshaft 120 is rotatable about its axisindependent of the screw blade 125, and the screw blade is rotatableabout its axis independent of the driveshaft. A distal end portion ofthe driveshaft 120 is operatively connected to the rotatable cutter 116for selectively driving rotation of the cutter generally about thelongitudinal axis LA₁ of the catheter body 112. The shank of thedriveshaft 120 is generally flexible and may be formed from one or morecoils (e.g., stainless steel coil(s)), or a torque tube (e.g., apolyimide tube with a layer of braided stainless steel wire embeddedtherein). The shank of the driveshaft 120 may have a very high torsionalstiffness and sufficient tensile strength, but which is generallylaterally flexible. Depending upon the desired torque transmission,diameter and flexibility, any of a variety of other materials andconstructions may also be used.

Referring to FIG. 1, the proximal end of the driveshaft 120 is operablyconnected to a cutter motor 130 (broadly, a cutter driver) to impartrotation of the driveshaft 120 relative to catheter body 112. In oneexample, the cutter motor 130 is disposed within a handle 132 (shownwith a cover removed in FIG. 1) that is releasably connectable to theproximal end of the catheter 110. For example, in addition to the cuttermotor 130, the handle 132 may house a power source 134 (e.g., batteries)for the cutter motor 130, a microswitch (not shown) for activatingcutter motor, and a catheter connector 136 for use in connecting themotor to the proximal end portion of the driveshaft 120. In someembodiments, the cutter motor 130 can rotate the driveshaft 120 between1,000 rpm and 10,000 rpm or more, if desired. As explained in moredetail below, the handle 132 may include one or more input devices, suchas actuator 133 (e.g., a switch or button), which is used to turn on(and turn off) the cutter driver 130 to selectively impart rotation ofthe driveshaft 120 and the cutter 116. It is understood that thedriveshaft 120 may be driven in other ways without departing from thescope of the present invention.

As seen best in FIGS. 5 and 7, the rotatable cutter 116 has oppositeproximal and distal ends and a longitudinal axis LA₂ (FIG. 7) extendingtherebetween. The cutter 116 has a generally cylindrical distal cuttingportion 142 and a proximal stem 144 (broadly, a driveshaft-connectionportion). The cutter 116 is fixed axially within the cutter housing 118.For example, the cutter housing 118 may function as a rotary bearing forsupporting the cutter 116 while allowing the cutter to rotate within thecutter housing. The cutter 116 may be formed as a single, one-piececonstruction, or may be formed from separate components secured to oneanother in a suitable manner, such as welding, soldering, adhesives,mechanical interference fit, threaded engagement and the like. As anon-limiting example, the cutter 116 may be comprised of steel, tungstencarbide, tungsten carbide cobalt, tungsten carbide molybdenum, siliconcarbide, silicon nitride, ceramic, amorphous metals or other materialsand may be manufactured by methods including turning, grinding,sintering, electro-discharge machining (EDM), laser cutting, heattreating, precipitation hardening, casting or other methods.

Referring still to FIGS. 6 and 7, the distal cutting portion 142 of thecutter 116 includes an annular cutting edge 150 at the distal endthereof, and an axial, through cavity 152, defined by an interiorsurface of the cutter 116, extending from the cutting edge through thestem 144 of the cutter. In one non-limiting example, the annular cuttingedge 150 is beveled from an exterior surface of the cutter toward theinterior surface to define a sharp, distal cutting edge 154. The cuttingedge 150 may be formed separately from the distal cutting portion 142 ofcutter 116 and attached thereto, or the cutting edge may be formedintegrally with the distal cutting portion of cutter. In the embodimentillustrated, shown best in FIG. 6, the beveled, annular cutting edge 150includes one or more raised elements 156 (e.g., breakers), although thecutting cutter 116 may have no raised elements without departing fromthe scope of the present invention. In the illustrated embodiment, fourraised elements 156 are formed on the beveled, annular cutting edge 150,although in other embodiments more than four or fewer than four raisedelements may be present. During removal of tissue from the target bodylumen, the raised elements 156 produce a hammer-like impact against thetissue to be removed as the cutter 116 is rotated. In the case where thetissue to be removed has brittle characteristics (e.g., has becomecalcified), the tissue will be crushed into smaller particles therebyfacilitating its removal. Repeated rotation of cutter 116 will producerepeated hammer-like blows of the cutter raised elements 156 against thetissue to be removed. Exemplary raised elements 156 are disclosed inU.S. Published Patent Application No. 2011/0130777 (Ser. No.12/958,488), filed Dec. 2, 2010, the entirety of which relating to theraised elements disclosed thereon are incorporated by reference herein.In other embodiments, the annular cutting edge 150 may have a generallysmooth surface. The cutting edge may be of other configurations withoutdeparting from the scope of the present invention.

The stem 144 connects the cutter 116 to the distal end of the driveshaft120 such that rotation of the driveshaft imparts rotation of the cutter116 about its longitudinal axis LA₂ (i.e., the rotational axis of thecutter is coincident with the central longitudinal axis of the cutter).In the illustrated embodiment, the distal end of the driveshaft 120 isreceived in an axial cavity 146 in the stem 144 and is secured therein,such as by soldering, welding, or in other ways. The axial cavity 152defined by the cutter 116 extends generally axially through the proximalend of the cutter 116 and is in communication with the tissue-transportpassage 123 defined by the driveshaft 120 so that tissue removed by thecutter passes through the axial cavity and into the tissue-transportpassage, where it is picked up and transported proximally by the screwblade 125, as explained in more detail below.

Referring to FIGS. 2, 3, and 5, the screw blade 125 extends through thedriveshaft 120 and the axial cavity 152 of the cutter 116. In oneembodiment (as shown in FIGS. 3 and 5), distal end portion of the screwblade 125 is operably connected to the cutter housing 118 at a locationdistal of the cutter 116. In particular, the distal end portion of thescrew blade 125 is connected to the cutter housing 118 via a rotarybearing mechanism, generally indicated at 160. The Illustrated bearingmechanism 160 constrains axial movement of the screw blade 125 relativeto the cutter housing 118, while allowing for the screw blade to rotateabout its axis relative to the cutter housing. The bearing mechanism 160also transmits axial force imparted by the screw blade 125 to the cutterhousing 118 to allow for opening and closing of the cutter housing, asexplained in more detail below. In the illustrated embodiment, thebearing mechanism 160 includes a pair of longitudinally spaced apartbearings 162 a, 162 b, and a roller fitting 164 secured to the distalend of the screw blade 125, and rotatably coupled to the bearings. Thedistal end portion of the screw blade 125 may be connected to cutterhousing 118 in other ways.

The screw blade 125 includes a helical thread 169 on the exterior of itsshank and extending longitudinally thereon so that rotation of the screwblade 125 about its axis moves removed tissue proximally within thetissue-transport passage 123 of the driveshaft 120. In the illustratedembodiment, the thread 169 is a right-handed thread (as viewed from theproximal end of the driveshaft screw blade 125), such that rotation ofthe screw blade clockwise (as viewed from the proximal end of the screwconveyor) relative to the tissue-transport passage 123 transports thetissue proximally. The tissue transport passage 123 and the screwconveyor thread 169 may extend back to the proximal end portion of thecatheter body 112 and may empty into a tissue receptacle (not shown).The tissue transport passage 123 and screw conveyor thread 169 may stopshort of the proximal end portion of the catheter body 112. The thread169 may be formed on the shank of the screw blade 125 in a suitablemanner.

In one example, the cross-sectional dimension (e.g., inner diameter) ofthe tissue-transport passage 123 is slightly greater than the majordiameter of the exterior thread 169 on the screw blade 125 so that thereis a small radial gap (or play) between the thread on the screw bladeand interior surface of the body 112 defining the tissue-transportpassage 123. In this example, the radial gap is such so as not toinhibit or impede rotation and axial movement of the screw blade 125 intissue-transport passage 123, and at the same time, substantiallyinhibit tissue from passing between the thread 122 on the screw bladeand the interior surface of the driveshaft 130 defining thetissue-transport passage. For example, the diameter of thetissue-transport passage 123 may be from about 0.001 in (0.025 mm) toabout 0.020 in (0.508 mm) greater than the major diameter of theexterior thread 169. In another embodiment, the radial gap between thethread 169 on the screw blade 125 and interior surface of driveshaft 120defining the tissue-transport passage 123 is such that removed tissue ispinched between the thread and the interior surface, withoutsubstantially macerating the tissue, to facilitate proximal movement ofthe tissue. For this embodiment, the radial gap may measure from about0.005 in (0.127 mm) to about 0.020 in (0.508 mm), and in one example,from about 0.010 in (0.254 mm) to about 0.015 in (0.381 mm). It isunderstood that in some embodiments the screw conveyor 122 may beomitted without departing from the scope of the present invention.

Referring to FIG. 1, the proximal end of the screw blade 125 is operablyconnected to a conveyor motor 166 (broadly, a conveyor driver) to impartrotation of the screw blade 125 relative to catheter body 112. In oneexample, the conveyor motor 166 is disposed within the handle 132 (shownwith a cover removed in FIG. 10) that is releasably connectable to theproximal end of the catheter 110. The power source 134 (e.g., batteries)may also power the conveyor motor 166, or a different power source maybe provided. A different microswitch (not shown) may be used to activatethe conveyor motor 166. A lever 140 (or other actuator) controlsrotation of the screw blade 125 via the conveyor motor 166. In theIllustrated embodiment, the lever 140 also imparts axial movement of thescrew blade 125 relative to the catheter body 112 in order to actuatethe deployment mechanism 124, as explained below. In one embodiment, theconveyor motor 166 is operable independent of the cutter motor 130 toallow for transportation of removed tissue even if the cutter 116 is notin operation. It is understood that the screw blade 125 may be driven inother ways without departing from the scope of the present invention.

As set forth above, the tissue removed from the blood vessel by thecutting edge 150 passes proximally through the cutter 116, toward thetissue-transport passage 123 of the cutter driveshaft 130. In theillustrated embodiment, the screw blade 125 picks up removed tissuewithin the axial cavity 152 in the cutter 116 because the screw bladeand the screw blade thread 169 extend through the cutter to a distallocation. Thus, as can be seen from FIG. 14, as the tissue is beingremoved, it enters the axial cavity 152 in the cutter 116, where it ispicked up by the screw blade 125, and transported proximally through thestem 144 of the cutter and into the tissue-transport passage 123, whereit continues to be transported proximally by the screw blade. It isunderstood that the screw blade 125 may be of other configurations inother embodiments of the catheter without departing from the scope ofthe present invention.

As set forth above, the catheter 110 includes the deployment mechanism124 for configuring the cutter 116 between the retracted position (FIGS.1 and 3) and the deployed, cutting position (FIGS. 4 and 5). Forpurposes of the disclosure, the deployment mechanism 124 is consideredpart of the catheter body 12, and in particular, part of the distal endportion of the catheter body. As also set forth above, the deploymentmechanism 124 includes the cutter housing 118. The cutter housing 118 isgenerally tubular and includes a proximal longitudinal portion 118 a, adistal longitudinal portion 118 b, a hinge portion 180 interconnectingthe proximal and distal longitudinal portions, and a cutter window 182generally diametrically opposite the hinge portion and intermediate theproximal and distal longitudinal portions. In general, the distallongitudinal portion 118 a is pivotable relative to the proximallongitudinal portion 118 b about the hinge portion 180 (generally havinga hinge axis A_(H2)) (FIG. 10) to selectively open the deploymentmechanism 124 and expose at least a portion of the cutting edge 150through the cutter window 182 (FIG. 5), and selectively close thedeployment mechanism so that cutting edge is stored in the cutterhousing (FIG. 3). More specifically, axial movement of the screw blade125 imparts a longitudinal or axial force to the bearing mechanism 160,which transmits the force to the distal longitudinal portion 118 b ofthe cutter housing 118. Because of the hinge portion 180, the axialforce transmitted to the distal longitudinal portion 118 b is translatedinto rotational movement of the distal longitudinal portion about thehinge portion (generally about the hinge axis A_(H)). It is understoodthat the polymer jacket 111, if one is present on the catheter body 112,does not substantially inhibit bending of the cutter housing 118 at thehinge portion 180.

To open the cutter housing 118 so that the cutting edge 150 is exposedthrough the window 182, the screw blade 125 is moved distally within thecatheter body 112, such as by moving the lever 140 distally on thehandle 132, whereby the distal longitudinal portion 118 b pivots aboutthe hinge portion 180, away from the cutter 116, and the cutting edge150 protrudes through the window. As shown in FIG. 4, in the openposition, a longitudinal axis LA₂ of the distal longitudinal portion 118b extends at an offset angle relative to a longitudinal axis of thecatheter body 212 (and the proximal longitudinal portion 118 a, which isgenerally coaxial with the catheter body). This offset angle may measurefrom about 15 degrees to about 45 degrees, or from about 20 degrees toabout 30 degrees. To close the cutter housing 174 so that the cuttingedge 150 does not protrude through the window 182 (e.g., the cuttingedge is housed within the housing), the screw blade 125 is movedproximally within the catheter body 112, such as by moving the lever 140proximally on the handle 132, whereby the distal longitudinal portion118 b pivots about the hinge portion 180, toward the cutter 116. Asshown in FIG. 3, in the closed configuration, the longitudinal axis LA₂of the distal longitudinal portion 118 b may be generally coaxial withthe longitudinal axis LA₁ of the catheter body 212 (and the proximallongitudinal portion 118 a). Although in the illustrated embodiment thescrew blade 125 functions as a longitudinal force-transmitting componentto transmit a longitudinal or axial force to the cutter housing 118 toimpart pivoting of the cutter housing 118 at the hinge portion 180, inother embodiments the screw blade may be replaced with another type oflongitudinal force-transmitting component to perform the same function.For example, in another embodiment an elongate, flexible member mayreplace the screw blade 125. This member may be capable transmittinglongitudinal forces to the cutter housing 118 due to compressive andtensile loads applied to the member to actuate opening and closing ofthe cutter housing.

As shown best in FIG. 8, the proximal and distal longitudinal portions118 a, 118 b, respectively, of the cutter housing 118 are generallytubular, although each may be of other shapes. The window 182 comprisesa generally arcuate cutout or opening extending around a partialcircumference of the cutter housing 118. The hinge portion 180 comprisesan arcuate line of weakness (e.g., a living hinge) 181 that runs arounda partial circumference of the cutter housing 118, generallydiametrically opposite that of the window 182. For example, the line orweakness 181 may extend circumferentially between two, circumferentiallyspaced apart arcuate slots 183 in the tubular housing 118. Additional,spaced apart arcuate slots 185 may be formed proximal of the arcuateslots 183, to allow for bending at the hinge portion 180. The cutterhousing 118 may comprise an integral, one-piece component. The window182 and arcuate slots 183 (and other openings) may be formed by cutting(e.g., laser cutting).

It is understood that in other embodiments, the hinge portion 180 may beof other configurations to allow for pivoting of the distal longitudinalportion 118 b relative to the proximal longitudinal portion 118 a. Forexample, the hinge portion 180 may comprise a hinge pin, a trunnion,another type of living hinge, or the like, that enables the distallongitudinal portion 118 b to pivot (broadly, deflect) relative to theproximal longitudinal portion 118 a, generally transverse to thelongitudinal axis LA₁.

Referring to FIGS. 13-18 and FIGS. 54-55, a second embodiment of acutter housing is generally indicated at 218. As shown in FIGS. 13 and14, the cutter housing 218 is installed in a second embodiment of thecatheter, generally indicated at 210, that is constructed similar to thecatheter 110, including a catheter body 212, a cutter driveshaft 220,and a screw blade 225, each of which may be similar or identical to thecorresponding components of the first catheter 110, and therefore,corresponding disclosure set forth with respect to the first catheter isequally applicable to the present embodiment. Referring to FIGS. 13-14and FIGS. 54-55, the cutter 216 is different than the cutter 116 of thefirst embodiment, although the cutter may also be similar or identicalto the cutter 116 of the first catheter 110. Unlike the cutter 116, thepresent cutter 216 includes a center hub 230 defining a central,longitudinal passage 230 a through which the screw blade 225 extends. Aplurality of longitudinal flutes 231 (e.g., two flutes) extendlongitudinally through the cutter 216. The flutes 231 are spaced apartaround the center hub 230. Tissue removed by the cutting edge 250 passthrough the flutes 231 and enter the tissue-transport passage 232defined by the driveshaft 220, where the removed tissue is picked up bythe rotating screw blade 225.

As with the first cutter housing 118, the present cutter housing 218includes a proximal longitudinal portion 218 a, a distal longitudinalportion 218 b, a hinge portion, generally indicated at 280,interconnecting the proximal and distal longitudinal portions, and acutter window 282 generally diametrically opposite the hinge portion andintermediate the proximal and distal longitudinal portions. The distallongitudinal portion 118 b includes a nosecone. Moreover, the screwblade 225 is rotatably secured to the distal longitudinal portion 118 bof the cutter housing 218 by a bearing mechanism 260, that may beidentical to the bearing mechanism set forth above with respect to thefirst catheter. In general, the distal longitudinal portion 218 b ispivotable relative to the proximal longitudinal portion 218 a about thehinge portion 280 (generally having a hinge axis A_(H2), FIG. 16) toselectively open the cutter housing 218 (broadly, to open the deploymentmechanism 224) and expose at least a portion of the cutting edge 250through the cutter window 282 (FIG. 14), and selectively close thecutter housing so that cutting edge is stored in the cutter housing(FIG. 13).

Referring to FIGS. 15-18, the cutter housing 218 is formed from aone-piece hypotube, such as a plastic or metal hypotube (e.g., stainlesssteel) or other type of hypotube. The window 282 is generally arcuate,extending generally circumferentially along a portion of thecircumference of the cutter housing 218, and has oppositecircumferential sides 283. For example, the window 282 may extend alongless than 50% of the circumference of the cutter housing 218. The hingeportion 280 comprises a plurality of arcuate slots 285 spaced apartalong the length of the hypotube. Each arcuate slot 285 extendsgenerally circumferentially from one circumferential side 283 of thewindow 282 toward the opposite circumferential side of the window andterminates adjacent to, but not in communication with, the oppositecircumferential side of the window. Adjacent arcuate slots 285 alternatesuch that adjacent slots do not extend from the same side of the window282 so as to form longitudinally spaced apart connecting portions 287adjacent the opposite sides of the window. As such, the hinge portion280 comprises a plurality of interconnected z-shape segments extendingalong the length of the cutter housing 218, which forms a metallicskeleton. A polymer jacket (not shown), such as disclosed above withrespect to the first embodiment, may be provided over the metallicskeleton. The window 282 and the hinge portion 280 (e.g., the slots orother openings forming the metallic skeleton) may be formed by cutting,such as laser cutting, the hypotube. In the illustrated embodiment, thecutter housing 218 is biased in its closed position, although the cutterhousing may be formed such that it is biased in its closed position.

An exemplary operation of the first catheter 110 is set forth below,with the understanding the disclosed operation is applies equally to thesecond catheter 210. The catheter 110 is inserted into the body lumen(e.g., artery) such that the cutter 116 is positioned adjacent thetarget site. Fluoroscopy or other imaging techniques may be used tofacilitate placement of the catheter 110 in the body lumen. Duringplacement of the catheter 110 in the body lumen, the cutter housing 118(broadly, the deployment mechanism 124) is closed and the cutter 116 isin the covered position. At the target site, the cutter housing 118 isopened, such as by moving the lever 140 on the handle 132 distally, toimpart distal movement of the screw blade 125 relative to the catheterbody 112 and the cutter housing 118. As the screw blade 125 movesdistally, the distal longitudinal portion 118 b of the cutter housing118 pivots relative to the proximal longitudinal portion 118 a about thehinge axis A_(H1) at the hinge portion 180 such that a portion of thecutting edge 150 of the cutter 116 extends through the cutter window 180defined by the cutter housing. As explained above, an urging mechanism(not shown) may urge the cutting edge 150 toward the wall of the bodylumen, and the offset distal longitudinal portion 118 b of the cutterhousing 118 may also facilitate urging of the cutting edge toward thelesion site.

With the cutter housing 118 open and the cutting edge 150 at leastpartially exposed through the window 180, the cutter driver 130 may beactivated to actuate rotation of the cutter driveshaft 120 and thecutter 116 relative to the catheter body 112. The screw blade 125 mayalso be activated, such as by moving the switch 133, or alternatively,the screw blade may be automatically activated upon moving the lever 140distally, which opens the cutter housing 118. The catheter 110 is moveddistally through the body lumen, whereby the rotating cutter 116 removestissue from the lesion site. The removed tissue is picked up by therotating screw blade 125 and transported proximally within thetissue-transport passage 123 in the catheter body 112. After making apass through the lesion site, the cutter housing 118 may be closed bymoving the screw blade 125 proximally, such as by moving the lever 140proximally, to impart pivoting of the distal longitudinal portion 118 bof the cutter housing 118 toward the cutter 116 about the hinge axisA_(H1) at the hinge portion 180. The cutter driver 130 may bedeactivated before or after closing the cutter housing 118, or thecutter driver may remain on. In one example, the screw blade 125 mayremain on (e.g., the user may keep the conveyor driver 133 on) afterclosing the cutter housing 118 so that screw blade continues totransport the removed tissue proximally within the catheter body 112.With the cutter housing 118 closed, the catheter 110 is moved proximallywithin the body lumen, to allow the practitioner to take another passthrough the lesion site.

Referring to FIGS. 19 and 20, a third embodiment of a tissue-removingcatheter is generally indicated at 310. With the exception of adeployment mechanism 324, the third catheter 310 may be constructedsimilar to the catheter 110, including a catheter body 312, a cutter 316(including a cutting edge 350), and a cutter driveshaft 320, each ofwhich may be similar or identical to the corresponding components of thefirst catheter 110, and therefore, corresponding disclosure set forthwith respect to the first catheter is equally applicable to the presentembodiment. In the illustrated embodiment, the catheter includes a screwblade 325 received in tissue-transport passage 323 defined by aninterior surface of the driveshaft 320. Unlike the previous catheterembodiments 110, 210, a distal end of the screw blade 325 terminatesproximal of the cutting edge 350 of the cutter 316. In otherembodiments, the cutter 316 and the driveshaft 320 may be of differentconfigurations, such as the driveshaft being solid.

The deployment mechanism 324 of the present catheter 310 comprises acutter housing 318 and an expandable member 319 that is configured toselectively expand in volume. The cutter housing 318 may besubstantially similar to the cutter housing 118 or 218, in that thecutter housing includes a proximal longitudinal portion 318 a, a distallongitudinal portion 318 b, a hinge portion 380 interconnecting theproximal and distal longitudinal portions, and a cutter window 382generally diametrically opposite the hinge portion and intermediate theproximal and distal longitudinal portions. The distal longitudinalportion 318 b includes a nosecone, which may include openings 381, suchthat the nosecone functions as an embolic basket. That is, the noseconemay function to catch tissue (e.g., debris) that is cut by the cutter316 but did not enter the cutter and the tissue. In general, the distallongitudinal portion 318 b is pivotable relative to the proximallongitudinal portion 318 a about the hinge portion 380 (generally havinga hinge axis A_(H3)) to selectively open the cutter housing 318(broadly, to open the deployment mechanism 224) and expose at least aportion of the cutting edge 350 through the cutter window 382 (FIG. 19),and selectively close the cutter housing so that cutting edge is storedin the cutter housing (FIG. 20).

The expandable member 319 is operatively connected to the cutter housing318 such that selective expansion of the expandable member from acontracted state (FIG. 19) to an expanded state (FIG. 20) impartsrotation or pivoting of the distal longitudinal portion 318 b of thecutter housing about the hinge axis A_(H3) at the hinge portion 380. Inthe illustrated embodiment, the cutter housing 318 is biased in an openposition (FIG. 19), whereby the distal longitudinal portion 318 bextends at an offset angle relative to the proximal longitudinal portion318 a (similar to the previous cutter housings 118, 218). Thus, when theexpandable member 319 is in its contracted state, the cutter housing 318is open and the cutting edge 350 of the cutter 316 is exposed, and whenthe expandable member is in its expanded state, the cutter housing isclosed and the cutting edge is covered by the distal longitudinalportion 318 b.

In the illustrated embodiment, the expandable member 319 comprises aninflatable balloon in fluid communication with a source of fluid (e.g.,saline) 390 via tubing 392 extending along the catheter body 312. In thedrawings, the tubing 392 is illustrated schematically and shownextending outside the catheter body 312 for ease of illustration, withthe understanding that the tubing may extend within the catheter body.The source of fluid 390 may be provided within a handle 332, which maybe similar to the handle 232, or separate from the handle. In thedrawings, the handle 332 is shown schematically and is not shownoperatively connected to the catheter body for ease of illustration,with the understanding that the handle would be operatively connected tothe catheter body similar to the previous embodiments. The handleincludes a cutter driver 330 similar to the cutter driver 230, and anactuator 333 (e.g., a button) for activating the cutter driver to driverotation of the driveshaft 325 and the cutter 316. A fluid pump 394 maybe used to deliver the fluid into the balloon. The handle (or some otherdevice) may include an actuator 396 (e.g., a button or switch) forselectively activating the fluid pump to deliver the fluid to theballoon, thereby inflating the balloon and closing the cutter housing318. To open the cutter housing 318, the fluid pump 394 or some otherdevice (e.g., a vacuum) may be selectively activated to withdrawal thefluid from the balloon, whereby the balloon deflates and the cutterhousing 318 opens.

An exemplary use of the catheter 310 may be similar to the exemplaryuses of the first catheter 110 set forth above, with the exception beingthat the cutter housing 318 is opened and closed using the expandablemember 319, as disclosed above.

Referring to FIGS. 21 and 22, a fourth embodiment of a tissue-removingcatheter is generally indicated at 410. The illustrated tissue-removingcatheter 410 is similar to the tissue-removing catheter 210, except thata cutter housing, generally indicated at 418, comprises heat-activating,shape-memory material, such as nitinol or other shape-memory material,and an electrical conductor 411 electrically connected to the cutterhousing 418 for delivering electrical current to the cutter housing foropening and closing the cutter housing, as explained below. With thanthese differences, the fourth catheter 410 may be constructed similar tothe catheter 210, including a catheter body 412; a cutter 416 having acutting edge 450; a cutter housing 418 having a window 482 and proximaland distal longitudinal portions 418 a, 418 b connected by a hingeportion 480; and a cutter driveshaft 420, each of which may be similaror identical to the corresponding components of the second catheter 210,and therefore, corresponding disclosure set forth with respect to thefirst catheter is equally applicable to the present embodiment. In theillustrated embodiment, the catheter 410 includes a screw blade 425received in tissue-transport passage 423 defined by an interior surfaceof the driveshaft 420. Like the third catheter embodiment 310, a distalend of the screw blade 425 terminates proximal of the cutting edge 450of the cutter 416. In other embodiments, the cutter 416 and thedriveshaft 420 may be of different configurations, such as thedriveshaft being solid.

In one example, the entire cutter housing 418 may comprise a single,one-piece construction comprising the shape-memory material (e.g.,nitinol). For example, the cutter housing 418 may be formed from ahypotube comprising nitinol or another shape-memory material. In anotherexample, only the hinge portion 480 comprises nitinol or anothershape-memory material, and the hinge portion 480 may be secured to theproximal and distal longitudinal portions 418 a, 418 b in a suitablefashion. The proximal and distal longitudinal portions 418 a, 418 b maybe formed from a different material, such as a rigid metal or plastic.

In the illustrated embodiment, the cutter housing 418 is configured suchthat the original, non-activated shape of the cutter housing is itsclosed position (FIG. 21) and the activated shape of the cutter housingis its open position (FIG. 22). The catheter 410 may include anelectrical power source 413 (e.g., a battery) that is electricallyconnected to the electrical conductor 411 (e.g., a cable or wire), whichis, in turn, electrical connected to the shape-memory material of thecutter housing 418. In the drawings, the electrical conductor 411 isillustrated schematically and shown extending outside the catheter body412 for ease of illustration. The power source 413 may be providedwithin a handle 432, which may be similar to the handle 232, or separatefrom the handle. In the drawings, the handle 432 is shown schematicallyand is not shown operatively connected to the catheter body 412 for easeof illustration, with the understanding that the handle would beoperatively connected to the catheter body similar to the previousembodiments. The handle 432 includes a cutter driver 430 similar to thecutter driver 230, and an actuator 433 (e.g., a button) for activatingthe cutter driver to drive rotation of the driveshaft 425 and the cutter416. The handle (or some other device) includes an actuator 496 (e.g., abutton or switch) for selectively activating the power source 413 tosupply electrical current to the cutter housing 418.

When electrical current is applied to the cutter housing 418, theshape-memory material is heated by resistive heating to a temperature ator above its transformation temperature, whereby the cutter housing 418bends at the hinge portion 480 (generally about a hinge axis A_(H4)) toopen the cutter housing and expose the cutter 416 (FIG. 22). To closethe cutter housing 418, the electrical power source 413 is deactivatedto cease the supply of electrical current to the cutter housing,whereupon the shape-memory material cools and rebounds to its original,closed position (FIG. 21).

An exemplary use of the catheter 410 may be similar to the exemplaryuses of the first catheter 110 set forth above, with the exception beingthat the cutter housing 418 is opened and closed by supplying electricalcurrent to the shape-memory material, as set forth above.

Referring to FIGS. 23-28, a fifth embodiment of a tissue-removingcatheter is generally indicated at 510. Briefly, the catheter 510includes an elongate tubular catheter body 512 having opposite proximaland distal ends, a central longitudinal axis LA₃ (FIG. 25) extendingbetween the distal and proximal ends, and an internal tissue-transportpassage 514 (FIGS. 21 and 22) extending generally along the longitudinalaxis of the body. The catheter body 512 may be similar to the catheterbody 110 of the first catheter 110, and therefore, correspondingdisclosure set forth with respect to catheter body of the first catheteris equally applicable to the present embodiment. Referring to FIGS.24-26, a rotatable cutter, generally indicated at 516, is operativelyconnected to the distal end of the catheter body 512 for removing tissuefrom a body lumen. A driveshaft 520 (FIGS. 24-26), which includes anexternal helical thread 522, drives rotation of the cutter 516 and alsotransports or moves removed tissue proximally within thetissue-transport passage 514 of the catheter body 512. A deploymentmechanism, generally indicated at 524, comprises a cutter housing 526that is configurable between a closed position (FIGS. 23 and 25), inwhich the cutter 516 is not exposed for cutting, and an open position(FIGS. 26 and 28), in which the cutter is exposed for cutting.

Referring to FIGS. 24-26, as set forth above, the catheter 510 includesthe rotatable cutter 516 and the driveshaft 520 for imparting rotationof the cutter. The driveshaft 520 extends along the tissue-transportpassage 514 of the catheter body 512 and, in the illustrated embodiment,is substantially fixed axially with respect to the catheter body. Adistal end portion of the driveshaft 520 is operatively connected to therotatable cutter 516 for selectively driving rotation of the cuttergenerally about the longitudinal axis LA₃ of the catheter body 512. Inthe illustrated embodiment, the distal end portion of the driveshaft 520is fixedly secured to the cutter 516. The shank of the driveshaft 520(i.e., the part of the driveshaft not including the thread 522) isgenerally flexible and may be formed from one or more coils (e.g.,stainless steel coil(s)), or a torque tube (e.g., a polyimide tube witha layer of braided stainless steel wire embedded therein). The shank ofthe driveshaft 520 may have a very high torsional stiffness andsufficient tensile strength, but which is generally laterally flexible.Depending upon the desired torque transmission, diameter andflexibility, any of a variety of other materials and constructions mayalso be used.

In the illustrated embodiment, the helical thread 522 on the exterior ofthe driveshaft 520 extends along the length of the driveshaft andfunctions as a transport mechanism for transporting removed tissueproximally within the tissue-transport passage 514 of the catheter body512. Accordingly, the threaded driveshaft 520 functions as an auger or ascrew conveyer, whereby rotation of the driveshaft imparts rotation ofthe helical thread 522, which moves removed tissue proximally within thecatheter body 512. In the illustrated embodiment, the thread 522 is aright-handed thread (as viewed from the proximal end of the driveshaft520), such that rotation of the driveshaft 520 clockwise (as viewed fromthe proximal end of the driveshaft 520) transports the tissueproximally. The tissue transport passage 514 and driveshaft thread 522may extend back to the proximal end portion of the catheter body 512 andmay empty into a tissue receptacle (not shown). The tissue transportpassage 512 and driveshaft thread 522 may stop short of the proximal endportion of the catheter body 512. The thread 522 may be formed on thedriveshaft 20 in a suitable manner.

Referring to FIG. 23, the proximal end of the driveshaft 520 is operablyconnected to a cutter motor 530 (broadly, a cutter driver) to impartrotation of the driveshaft 520 relative to catheter body 512. In oneexample, the cutter motor 530 is disposed within a handle 532 (shownwith a cover removed in FIG. 23) that is releasably connectable to theproximal end of the catheter 510. For example, in addition to the cuttermotor 530, the handle 532 may house a power source 534 (e.g., batteries)for the cutter motor 530, a microswitch (not shown) for activatingcutter motor, and a catheter connector 536 for operatively connectingthe motor to the proximal end portion of the driveshaft 520. In someembodiments, the cutter motor 30 can rotate the driveshaft 520 between1,000 rpm and 10,000 rpm or more, if desired. As explained in moredetail below, the handle 532 may include one or more input devices, suchas lever 540, which controls operation of the cutter motor 530. It isunderstood that the driveshaft 520 may be driven in other ways withoutdeparting from the scope of the present invention.

As seen best in FIGS. 24-26, the rotatable cutter 516 has oppositeproximal and distal ends and a longitudinal axis extending therebetween.The cutter 516 has a generally cylindrical distal cutting portion 542, aproximal stem 544 (broadly, a driveshaft-connection portion) forconnecting the cutter to the driveshaft 524, and a transitional portion546 intermediate the distal cutting portion and the stem. The distalcutting portion 542 of the cutter 516 includes an annular cutting edge550 at the distal end thereof, and an axial cavity 552, defined by aninterior surface of the cutter 516, extending from the cutting edgetoward the stem 544 of the cutter. In one non-limiting example, theannular cutting edge 550 is beveled from an exterior surface of thecutter toward the interior surface to define a sharp, distal cuttingedge 554. A plurality of raised element 556 (FIGS. 25 and 26) are alsoformed on the annular cutting edge 550, the details of which aredisclosed in U.S. patent application Ser. No. 12/958,488, filed Dec. 2,2010, the relevant teachings of which relating to the raised elementsdisclosed thereon are incorporated by reference herein, although theraised elements may be omitted. The exterior surface of the distalcutting portion 542 has a circumferential groove 548 formed therein inwhich bearing pins 555 on the interior surface of the catheter body 512are received to allow the cutter 516 to rotate about its axis, whilerestricting axial movement of the cutter relative to the catheter body.It is understood that a separate bearing member (not shown) may beprovided for the cutter 516. This bearing member would be consideredpart of the catheter body 522.

The cutter 516 has an eccentric opening 558 in communication with theaxial cavity 552 to allow removed tissue to pass through the cutter.Together, the eccentric opening 558 and the axial cavity 552 define atissue passage extending through the cutter 516. As can be seen fromFIGS. 25 and 26, as the tissue is being removed, it enters the axialcavity 552, and then passes through the eccentric opening 558 and intothe tissue-transport passage 514, where it can be picked up by thedriveshaft thread 522 (or other transport mechanism), and transportedproximally within the catheter body 512. The eccentric opening 558 inthe cutter 516 is offset with respect to the longitudinal axis (androtational axis) of the cutter.

The cutter 516 may be formed as a single, one-piece construction, or maybe formed from separate components secured to one another in a suitablemanner, such as welding, soldering, adhesives, mechanical interferencefit, threaded engagement and the like. As a non-limiting example, thecutter 516 may be comprised of steel, tungsten carbide, tungsten carbidecobalt, tungsten carbide molybdenum, silicon carbide, silicon nitride,ceramic, amorphous metals or other materials and may be manufactured bymethods including turning, grinding, sintering, electro-dischargemachining (EDM), laser cutting, heat treating, precipitation hardening,casting or other methods. The cutter 516 may be of other configurationswithout departing from the scope of the present invention.

As set forth above, the deployment mechanism 524 includes a cutterhousing 526 that opens to expose the cutter 516, and closes to cover thecutter. As shown best in FIG. 24, the cutter housing 526 includes agenerally cylindrical housing body 559, a cutter window 560, and linksor housing arms 562 (e.g., two arms) extending longitudinally outwardfrom a proximal end of the housing body. For reasons explained below,each housing arm 562 includes an inner pin 564 extending inward towardthe opposite housing arm and a pin opening 566 disposed proximal of thecorresponding pin. The cutter housing 526 is operatively connected to alongitudinal force-transmitting member, generally indicated at 570, forimparting movement of the cutter housing between its open and closedpositions. The force-transmitting member 570 includes a sleeve 572slidably fitted over the catheter body 512, and slide arms 573—whichinclude pivot pins 574 rotatable received in the respective pin openings566, as explained below—extending longitudinally outward from the distalend of the sleeve. Although in the drawings the sleeve 572 isillustrated as having a proximal end that terminates distal of thehandle, the sleeve is operatively connected to the handle 532 (e.g., thesleeve may extend to the handle) for imparting longitudinal movement ofthe sleeve relative to the catheter body 512 and the cutter 516. Inparticular, in the illustrated embodiment (FIG. 1) the sleeve 572 isoperatively connected to an actuator 576 (e.g., a lever) on the handle532 for imparting longitudinal movement of the sleeve. For example,movement of the lever 576 proximally imparts proximal movement of thesleeve 572, and movement of the lever distally imparts distal movementof the sleeve. It is understood that the force-transmitting member 570may be of other configurations.

As shown best in FIGS. 24, 27, and 28, the housing pins 564 and theslide arms 573 are slidably received in slots 580 defined bycorresponding tracks 582 secured adjacent to and extendinglongitudinally outward from the distal end of the catheter body 512.Only one track 582 is visible in FIGS. 24, 27, and 28, with the othertrack being generally diametrically opposite the visible track andsubstantially identical. As shown in FIGS. 27 and 28, the slot 580 has aproximal portion, generally indicated at 580 a, extending generallylongitudinally relative to the catheter body 512, and a distal portion,generally indicated at 580 b, extending at an angle offset from theproximal portion and the longitudinal axis of the catheter body. Thecorresponding slide arm 573 is slidably translatable in the proximalportion 580 a for generally longitudinal movement therein. The slide arm573 is generally not slidably translatable in the distal portion 580 b.The corresponding housing pin 564 is slidably translatable in the distalportion 580 b and may be slidably translatable in the proximal portion580 b, although this is not necessary.

As shown in FIG. 27, when the cutter housing 526 is in its closedposition, each housing pin 564 is substantially aligned longitudinally,with respect to the catheter body 512, with the corresponding pivot pin574 associated with the same housing arm 562. In this closed position,the lever 576 of the illustrated embodiment is in the proximal position.To open the cutter housing 526, the longitudinal force-transmittingmember 570 is moved distally, such as by moving the lever 576 on thehandle 532 distally. As the longitudinal force-transmitting member 570moves distally, each slide arm 573 slides distally within thecorresponding track 582 and imparts distal movement of the cutterhousing 526 by virtue of connection of the pivot pins 574 with thecorresponding housing arms 562 of the cutter housing. As the cutterhousing 526 moves distally, the housing pins 564 track along the distalportions 580 b of the respective track slots 580, while simultaneously,the cutter housing pivots or rotates about the pivot pins 574 on theslide arms 573 of the force-transmitting member 570. In effect, thecutter housing 526 rotates away from the cutter 516 about a hinge axisA₅ extending through the pins 574, such that a longitudinal axis LA₄ ofthe cutter housing extends at an offset angle relative to thelongitudinal axis LA₃ of the catheter body 512 (FIG. 28). This offsetangle may measure from about 15 degrees to about 45 degrees, or fromabout 20 degrees to about 30 degrees. With the cutter housing extendingat the offset angle, a portion of the cutting edge is exposed throughthe cutter window 560, as shown in FIGS. 26 and 28. To close the cutterhousing 526, the longitudinal force-transmitting member 570 is movedproximally, such as by moving the lever 576 proximally, whereby the pins564 track proximally in the distal portions 580 b of the slots 580 andthe pins 574 track proximally in the proximal portions 580 a of theslots to impart rotation of the cutter housing toward the cutter 516about the hinge axis A_(H5).

An exemplary use of the catheter 510 may be similar to the exemplaryuses of the first catheter 110 set forth above, with the exception beingthat the cutter housing 518 is opened and closed by longitudinallymoving the force-transmitting member 570, as set forth above.

Referring to FIGS. 29 and 30, in one example the catheter 510 mayfurther include a tissue director, generally indicated at 588, fordirecting tissue removed by the cutter 516 proximally within the axialcavity 552 of the cutter. The illustrated tissue director 588 is alsoconfigured for directing removed tissue circumferentially relative toaxial cavity 552 toward the eccentric opening 558 (FIG. 30) tofacilitate movement of the removed tissue through the cutter 516 wherethe removed tissue can be picked up by the helical thread 522. Althoughthe illustrated tissue director 588 is associated with the catheter 510,it is understood that the tissue director may be incorporated in adifferent catheter having a deflectable distal tip or other deploymentmechanism and a cutter that allows removed tissue to pass therethrough.

Referring to FIG. 30, the tissue director 588 includes a distal tongueportion 589 attached within the housing body 559 (or other deflectabledistal tip member), and a proximal flute portion 590 extendingproximally from the tongue portion and received in the axial cavity 552of the cutter 516. The flute portion 590 is free from attachment to thecutter 516 so that the cutter 516 is rotatable about the flute portion.The flute portion 590 has a length L_(F) (FIG. 32) extending generallyaxially within the axial cavity 552 from adjacent the distal tip 554 ofthe cutter 516 to adjacent the eccentric opening 558 (FIG. 30), and awidth W_(F) (FIG. 33) extending generally across the axial cavity (e.g.,diametrically across the axial cavity). As shown best in FIGS. 31 and32, the flute portion 590 defines a groove or fluting 592 extendingalong the length L_(F) of the flute portion. The fluting 592 extendsalong a counterclockwise or left-handed helical path as viewed from thedistal end of the catheter 510, and in the illustrated embodiment, thedirection of the helical path of the fluting (e.g., counterclockwisedirection) is the same as the direction that the cutter 516 rotates(e.g., counterclockwise).

As shown in FIG. 30, when the housing body 559 is open, the tongueportion 589 has a bend or curve 589 a. When the housing body 559 isclosed, the tongue portion 589 may straighten or buckle or otherwise beconfigured in a shape that allows the tissue director 588 to fit withinthe axial cavity 552 of the cutter 516. Accordingly, the tissue director588 may be flexible along its length L_(F), and in one embodiment, thetissue director is resiliently deflectable along its length and biasedin the illustrated shape when the housing body 559 is open to properlyposition the flute portion 590 in the axial cavity, as shown in FIG. 30.As shown in FIGS. 30 and 32, when the housing body 559 is open, aleading longitudinal edge 594 of the flute portion gradually falls awayfrom (i.e., slopes radially away from) the rotational axis of the cutter516 and toward the interior wall defining the axial cavity 552. Astissue is removed by the rotating cutter 516, the flute portion 590directs the removed tissue both circumferentially and proximally withinthe axial cavity 552 to inhibit the removed tissue from passing backthrough the open distal end 554 of the cutter.

Referring to FIGS. 34 and 35, another example of a tissue director,generally indicated at 588′, is incorporated in the catheter 510 and isconfigured for directing tissue removed by the cutter 516 proximallytoward the cutter and into the axial cavity 552 of the cutter. Althoughthe Illustrated tissue director 588′ is associated with the catheter510, it is understood that the tissue director may be incorporated in adifferent catheter having a deflectable distal tip or other deploymentmechanism. The tissue director 588′ includes a rotatabletissue-directing member, generally indicated at 590′, and a bearingmember 592′. The tissue-directing member 590′ includes a proximal head593′ located distal of and in opposing relationship with the cutter 516,and a stem 594′ that is rotatably coupled to the bearing member 592′ forrotation about its axis. The head 593′ is generally disk-shaped and isoperatively coupled to the cutter 516 so that rotation of the cutterdrives rotation of the tissue director 590′. A face of the head 593′faces proximally and may have a shape or contour to facilitate directingremoved tissue toward the cutter 516 as the head 593′ rotates. In theillustrated embodiment, the head 593′ is coupled to the cutter 516 bygearing 595′. In particular, the cutter 516 may include a gear (e.g.,teeth) extending circumferentially adjacent the distal tip 554 and inengagement with the gearing 595′, and the head 593′ may also include agear (e.g., teeth) extending circumferentially adjacent its proximal endand in engagement with the gearing 595′. In one embodiment, the gearing595′ is configured to counter-rotate the head 593′ in a directionopposite that of the cutter 516. In another embodiment, which may notinclude the gearing 595′, the head 593′ may rotate in the same directionas the cutter 516. In another embodiment, the head 593′ may be directlycoupled to the cutter 516, such as by bringing the gears of the twocomponents in engagement with one another.

In the illustrated embodiment, the bearing member 592′ is movablelongitudinally within the cutter housing body 559. In this embodiment,the tissue director 588′ also includes a biasing member 596′ (e.g., aspring) for biasing the bearing member 592′ and/or the head 593′, towardthe cutter 516 to maintain the mechanical coupling between the cutterand the head 593′ (e.g., maintain the engagement between the gearing595′ and the cutter and the head) when the cutter housing body 559 isopen (FIG. 35). In another embodiment, the bearing member 596′ and thehead 593′ may be fixed longitudinally within the cutter housing body 559and positioned so that the bearing member head 593′ couples to thecutter 516 when the cutter housing is open.

Referring to FIGS. 36-41, a sixth embodiment of a tissue-removingcatheter is generally indicated at 610. Briefly, the catheter 610includes an elongate tubular catheter body 612 having opposite proximaland distal ends, a central longitudinal axis LA₅ (FIG. 40) extendingbetween the distal and proximal ends, and an internal tissue-transportpassage 614 (FIGS. 39 and 41) extending generally along the longitudinalaxis of the body. The catheter body 612 may be similar to the catheterbody 112 of the first catheter 110, and therefore, correspondingdisclosure set forth with respect to catheter body of the first catheteris equally applicable to the present embodiment. Referring to FIGS. 37,39, and 41, a rotatable cutter, generally indicated at 616, isoperatively connected to the distal end of the catheter body 612 forremoving tissue from a body lumen, and a driveshaft 620, which includesan external helical thread 622, drives rotation of the cutter 616 andalso transports or moves removed tissue proximally within thetissue-transport passage 614 of the catheter body 612. The cutter 616and the driveshaft 620 may be substantially similar to the cutter 516and driveshaft 520 of the fifth embodiment, and therefore, correspondingdisclosure set forth with respect to catheter body of the fifth catheteris equally applicable to the present embodiment. Moreover, as shown inFIG. 36, the driveshaft 620 is operatively connected to a cutter driver630 (e.g., a cutter motor) in a handle 632 for imparting rotation of thedriveshaft. The handle 632 also includes an actuator 640 (e.g., a lever)for activating the cutter driver 630 and a power source 634 forsupplying power to the cutter driver. A deployment mechanism, generallyindicated at 624, comprises a cutter housing 626 that is configurablebetween a closed position (FIGS. 36, 38, and 39), in which the cutter616 is not exposed for cutting, and an open position (FIGS. 40 and 41),in which the cutter is exposed through a cutting window 659 defined bythe cutter housing.

Referring to FIGS. 36-41, a housing adaptor 660 is secured to the distalend of the catheter body 612. For purposes of this disclosure, thehousing adaptor 660 is considered part of the catheter body 612. Aproximal end portion of the cutter housing 626 is pivotably connected tothe housing adaptor 660 by pins 662 (only one pin is visible in FIGS.3638 and 40; the other pin is at a location diametrically opposite thevisible pin). As explained below, the cutter housing 626 is selectivelypivotable about the pins 662 for opening and closing the cutter housing618.

Referring to FIGS. 37, 39, and 41, a cam shaft, generally indicated at666, extends through a cam passage 668 extending longitudinally throughthe catheter body 612, including the housing adaptor 660. The cam shaft666 includes a tubular torque shaft 670 (e.g., a torque tube), a cutteradaptor 672 fixedly secured to and extending longitudinally outward froma distal end of the torque shaft, and an eccentric 674 fixedly securedto a distal end of the cutter adaptor. The torque shaft 670 is rotatableabout its longitudinal axis relative to the catheter body 612. Aproximal end of the torque shaft 670 is operatively connected to thehandle 632 for imparting rotation of the shaft about its longitudinalaxis. In particular, referring to FIG. 36 the handle 632 may include anactuator 676 (e.g., a lever or knob) for imparting rotation to thetorque shaft 670. In one example, the actuator 676 is a manual actuatorfor manually rotating the torque shaft 670. In another example, such asillustrated, the actuator 676 activates a cam motor 678 that isoperatively connected to the torque shaft 670 to impart rotation to thetorque shaft. The torque shaft 670 may be rotatable in other ways.

Rotation of the torque shaft 670 about its axis imparts rotation of thecutter adaptor 672 about the axis of the torque shaft, relative to thecutter 616 and the catheter body 612. The cutter adaptor 672 includesbearing pins 680 (FIGS. 39 and 41) received in a circumferential groove648 on the cutter 616 to allow for rotation of the cutter adaptor (andthe cam shaft 666) relative to the cutter, and vice versa. Thetissue-transport passage 614 is defined by interior surfaces of thecutter adaptor 672 and the torque shaft 668. In the illustratedembodiment, tissue cut by the cutter 616 travels through the cutter 616and into the tissue-transport passage 614, where the removed tissue ispicked up by the rotating driveshaft 620 and transported proximallywithin the catheter body 612.

Rotation of the torque shaft 670 about its axis also imparts rotation ofthe eccentric 674 about the axis of the torque shaft 670 relative to thecutter housing 626. The eccentric 674 interacts with a cam follower 684secured to (e.g., secured within) the cutter housing 626 to driveopening and closing of the cutter housing. Together, the eccentric 674and the cam follower 684 constitute a cam mechanism. More specifically,when the cutter housing 626 is in the closed position, a generally flatsurface 674 a (e.g., a longitudinally truncated portion) opposes anengagement surface 688 of the cam follow 684, and an arcuate surface 674b of the eccentric is adjacent the cutter window 659. As the eccentric674 rotates about the axis of the torque shaft 670, the engagementsurface 688 of the cam follower 684 rides along an arcuate surface 674 bof the eccentric, whereby the cutter housing 626 pivots or rotates aboutthe hinge pins 662 (e.g., hinge axis A_(H6)), away from the cutter 616,and a portion of the cutting edge 650 of the cutter 616 is exposedthrough the cutter window 659. When the eccentric 674 is rotated about180 degrees from its position when the cutter housing 626 is closed, theflat surface 674 a is adjacent the cutter window, and the cutter housingis fully open, as shown in FIG. 40. In the fully open position, thelongitudinal axis LA₆ of the cutter housing 626 extends at an offsetangle relative to the longitudinal axis LA₅ of the catheter body 612.This offset angle may measure from about 15 degrees to about 45 degrees,or from about 20 degrees to about 30 degrees. As shown in FIG. 41, theradial extent of the flat surface 674 a is less than that of the cuttingedge 650 of the cutter 616, such that the eccentric does not cover theexposed portion of the cutting edge of the cutter when the cutterhousing is in the open position. In one embodiment, amount by which thecutting edge 650 is exposed is adjustable by allowing the eccentric 674to be rotated incrementally to different rotational positions, whichwould allow for selective adjustment of the offset angle. To close thecutter housing 626, the eccentric 674 is rotated to its initial positionwhen the cutter housing is closed, such that the cutter housing pivotstoward the cutter 616 about the pins 662.

An exemplary use of the catheter 610 may be similar to the exemplary useof the first catheter 110 set forth above, with the exception being thatthe cutter housing 626 is opened and closed by rotating the cam shaft666, as set forth above.

Referring to FIGS. 42 and 43, in one example the catheter 610 mayfurther include a tissue director, generally indicated at 690, fordirecting tissue removed by the cutter 616 proximally within the axialcavity 652 of the cutter. The illustrated tissue director 690 is alsoconfigured for directing removed tissue circumferentially relative toaxial cavity 652 toward the eccentric opening 658 (FIG. 43) tofacilitate movement of the removed tissue through the cutter 616 wherethe removed tissue can be picked up by the helical thread 622. Althoughthe illustrated tissue director 690 is associated with the catheter 610,it is understood that the tissue director may be incorporated in adifferent catheter having a deflectable distal tip or other deploymentmechanism.

The illustrated tissue director 690 is secured to the eccentric 674 andextends proximally therefrom into the axial cavity 652 of the cutter616. The tissue director 690 may be formed separately from and attachedto the eccentric 674 or formed integrally with the eccentric. The tissuedirector 690 may be relatively rigid and free from attachment to thecutter 616 so that the cutter is rotatable about the tissue director.The tissue director 690 has a length L_(TD) (FIG. 43) extendinggenerally axially within the axial cavity 652 from adjacent the distaltip 654 of the cutter 616 to adjacent the eccentric opening 658, and awidth W_(TD) (FIG. 44) extending generally across the axial cavity(e.g., diametrically across the axial cavity). Referring to FIGS. 44 and45, the tissue director 690 defines a groove or fluting 692 extendingalong the length L_(TD) of the tissue director. The fluting 692 extendsalong a counterclockwise or left-handed helical path as viewed from thedistal end of the catheter 610, and in the illustrated embodiment, thedirection of the helical path of the fluting (e.g., counterclockwisedirection) is the same as the direction that the cutter 616 rotates(e.g., counterclockwise). A leading longitudinal edge 694 of the fluteportion gradually falls away from (i.e., slopes radially away from) therotational axis of the cutter 616 and toward the interior wall definingthe axial cavity 652.

As tissue is removed by the rotating cutter 616, the tissue director 690directs the removed tissue both circumferentially and proximally withinthe axial cavity 652 to inhibit the removed tissue from passing backthrough the open distal end 654 of the cutter. It is understood that thetissue director 690 may be incorporated in other catheters other thanthe illustrated catheter 610.

Referring to FIGS. 46-53, a seventh embodiment of a tissue-removingcatheter is generally indicated at 710. Briefly, the catheter 710includes an elongate tubular catheter body 712 having opposite proximaland distal ends, a central longitudinal axis LA₇ (FIG. 48) extendingbetween the distal and proximal ends, and an internal tissue-transportpassage 714 (FIGS. 49 and 51) extending generally along the longitudinalaxis of the body. The catheter body 712 may be similar to the catheterbody 112 of the first catheter 110, and therefore, correspondingdisclosure set forth with respect to catheter body of the first catheteris equally applicable to the present embodiment. Referring to FIGS. 47,49, and 51, a rotatable cutter, generally indicated at 716, isoperatively connected to the distal end of the catheter body 712 forremoving tissue from a body lumen (e.g., a blood vessel), and adriveshaft 720, which includes an external helical thread 722, drivesrotation of the cutter 716 and also transports or moves removed tissueproximally within the tissue-transport passage 714 of the catheter body712. The cutter 716 and the driveshaft 720 may be substantially similarto the cutter 516 and driveshaft 520 of the fifth embodiment, andtherefore, corresponding disclosure set forth with respect to catheterbody of the fifth catheter is equally applicable to the presentembodiment. Moreover, the driveshaft 720 is operatively connected to acutter driver 730 (e.g., a cutter motor) in a handle 732 for impartingrotation of the driveshaft. The handle 732 also includes an actuator 740(e.g., a lever) for activating the cutter driver 730 and a power source734 for supplying power to the cutter driver. A deployment mechanism,generally indicated at 724, comprises a cutter housing 726 that isconfigurable between a closed position (FIGS. 46, 48, and 49), in whichthe cutter 716 is not exposed for cutting, and an open position (FIGS.35 and 36), in which the cutter is exposed.

Referring to FIGS. 49 and 51, the catheter body 712 includes bearingpins 780 received in a circumferential groove 748 on the cutter 716 toallow for rotation of the cutter relative to the catheter body. Thetissue-transport passage 714 is defined by interior surface of thecatheter body 712. In the illustrated embodiment, tissue cut by thecutter 716 travels through the cutter 716 and into the tissue-transportpassage 714, where the removed tissue is picked up by the rotatingdriveshaft 720 and transported proximally within the catheter body 712.For reasons explained below, a cone-shaped guard, generally indicated at784, is fixedly secured to the distal end of the catheter body 712,immediately distal the cutter 716. The guard 784 is truncatedlongitudinally, whereby a truncated or flat longitudinal portion 784 aof the guard has a radial extent, relative to the longitudinal axis LA₇of the catheter body 712, that is less than the radial extent of thecutting edge 750 of the cutter 716. As such, the truncated longitudinalportion 786 a does not cover a portion of the cutting edge 750 of thecutter 716.

A torque-transmitting member 770 (e.g., a torque tube) is coaxiallyreceived around the catheter body 712 and has a distal end that isfixedly secured to a proximal end of the cutter housing 726. Althoughnot illustrated as such in the drawings, a proximal end of thetorque-transmitting member 770 is operatively connected to the handle732 for selectively imparting rotation of the torque-transmitting memberabout its axis relative to the catheter body 712. In particular,referring to FIG. 46 the handle 732 may include an actuator 776 (e.g., alever or knob) for imparting rotation to the torque-transmitting member770. In one example, the actuator 776 is a manual actuator for manuallyrotating the torque-transmitting member 770. In another example, such asillustrated, the actuator 776 activates a torque motor 778 that isoperatively connected to the torque-transmitting member 770 to impartrotation to the torque tube. The torque-transmitting member 770 may berotatable in other ways.

The cutter housing 726 has a longitudinal axis LA₈ (FIGS. 49 and 50)extending at an offset angle relative to the longitudinal axis of thecatheter body 712. The cutter housing 726 has a generally cone shape,including a longitudinal flat or truncated portion 726 a and an arcuateportion 726 b. A radial extent of the truncated portion 726 a is lessthan the radial extent of the cutting edge 750 of the cutter 716, withrespect to the longitudinal axis LA₇ of the catheter body 712 so that aportion of the cutting edge adjacent to the truncated portion is notcovered by the cutter housing 726. A clearance opening 786 extendsgenerally longitudinally through a proximal end of the cutter housing726 and radially through the truncated portion 726 a. As shown in FIGS.50, 51 and 53, the cone-shaped guard 784 is receivable in the clearanceopening 786 when the cutter housing 726 is rotated to its open position.The size and shape of the clearance opening 786 are generallycomplementary to the cone-shaped guard 784. A clearance opening 790(FIGS. 50 and 53) for the cutting edge 750 of the cutter 716 extendslongitudinally through the distal end of the torque-transmitting member770.

As shown in FIGS. 48 and 49, when the cutter housing 726 is in itsclosed position, the cutter guard 784 covers a portion of the cuttingedge 750 of the cutter 716, as set forth above, and the cutter housing726 covers the remainder of the cutting edge that is not covered by thecutter guard. To open the cutter housing 726 and expose a portion of thecutting edge 750, the cutter housing 726 is rotated by thetorque-transmitting member 770 about the axis of the torque-transmittingmember (which is generally coaxial with the longitudinal axis LA₇ of thecatheter body 712), such as by using the actuator 776. Referring to FIG.52, as the cutter housing 726 rotates (in the direction indicated inFIG. 52), the cutter guard 784 enters the clearance opening 786 (i.e.,the cutter housing rotates about the cutter guard). The cutter housing726 is in its open position when the truncated portion of the cutterhousing is generally flush (e.g., coplanar) with the truncated portionof the cutter guard (FIGS. 51 and 53). In this position, a portion ofthe cutting edge 250 of the cutter 216 is exposed.

An exemplary use of the catheter 710 may be similar to the exemplary useof the first catheter 110 set forth above, with the exception being thatthe cutter housing 726 is opened and closed by rotating thetorque-transmitting member 770, as set forth above.

Having described embodiments of the invention in detail, it will beapparent that modifications and variations are possible withoutdeparting from the scope of the invention defined in the appendedclaims.

When introducing elements of the present invention or the preferredembodiments(s) thereof, the articles “a”, “an”, “the” and “said” areintended to mean that there are one or more of the elements. The terms“comprising”, “including” and “having” are intended to be inclusive andmean that there may be additional elements other than the listedelements.

As various changes could be made in the above constructions, products,and methods without departing from the scope of the invention, it isintended that all matter contained in the above description and shown inthe accompanying drawings shall be interpreted as illustrative and notin a limiting sense.

What is claimed is:
 1. A tissue-removing catheter comprising: anelongate catheter body configured for insertion into a body lumen of asubject, the catheter body having opposite distal and proximal ends, alongitudinal axis extending between the distal and proximal ends; acutter located generally at the distal end of the catheter body adaptedto remove tissue from the body lumen, the cutter having a proximal endportion, a distal end portion, and a longitudinal axis extending betweenthe proximal and distal end portions; a cutter housing adjacent thedistal end of the catheter body, the cutter housing including a distallongitudinal portion located distal of the cutter, wherein the distallongitudinal portion is pivotable generally about a hinge axis, relativeto the cutter between a closed position, in which the cutter is coveredby the cutter housing, and an open position, in which at least a portionof the cutter is exposed; a force-transmitting member extending alongthe catheter body and being longitudinally movable relative to thecatheter body, wherein a distal end portion of the force-transmittingmember is operatively connected to the distal longitudinal portion ofthe cutter housing such that distal movement of the force-transmittingmember relative to the catheter body and the cutter imparts pivoting ofthe distal longitudinal portion of the cutter housing to its openposition to expose the cutter; and a track located adjacent the distalend of the catheter body, the track defining a slot having an offsetportion extending at an offset angle relative to the longitudinal axisof the catheter body, wherein the cutter housing is configured to trackalong the offset portion of the slot when the force-transmitting memberis moved distally relative to the catheter body; wherein the slot has ashape and the shape of the slot is the same when the cutter housing isin the open position and the closed position.
 2. The tissue-removingcatheter set forth in claim 1, wherein the cutter housing is pivotablysecured to the force-transmitting member.
 3. The tissue-removingcatheter set forth in claim 2, wherein the force-transmitting memberincludes a sleeve slidably received over the catheter body, and a pairof slide arms extending longitudinally outward from a distal end of thesleeve, wherein the cutter housing is pivotably secured to the slidearms.
 4. The tissue-removing catheter set forth in claim 3, wherein eachof the slide arms includes a pivot pin received in a respective one of apin opening defined the cutter housing.
 5. The tissue-removing catheterset forth in claim 4, wherein the hinge axis extends through the pivotpins.
 6. The tissue-removing catheter set forth in claim 3, wherein theslot comprises a pair of slots having respective offset portions, eachslot further having a longitudinal portion in registration with anoffset portion of said respective offset portions, wherein the pair ofslide arms are slidably received in respective longitudinal portions ofthe slots.
 7. The tissue-removing catheter set forth in claim 6, whereinthe cutter housing includes housing pins received in respective slots,wherein the housing pins are configured to slidably translate in therespective offset portions of the slots.
 8. The tissue-removing catheterset forth in claim 7, wherein the housing pins are configured toslidably translate in the respective longitudinal portions of the slots.9. The tissue-removing catheter set forth in claim 1, wherein the trackcomprises a pair of tracks secured adjacent to and extendinglongitudinally outward from the distal end of the catheter body.
 10. Thetissue-removing catheter set forth in claim 9, wherein the tracks arediametrically opposite one another on the catheter body.
 11. Thetissue-removing catheter set forth in claim 1, wherein a longitudinalaxis of the cutter housing extends at an offset angle relative to thelongitudinal axis of the catheter body when the distal longitudinalportion of the cutter housing is pivoted about the hinge axis to itsopen position.
 12. The tissue-removing catheter set forth in claim 11,wherein the offset angle measures from about 15 degrees to about 45degrees.
 13. The tissue-removing catheter set forth in claim 11, whereinthe offset angle measures from about 20 degrees to about 30 degrees. 14.The tissue-removing catheter set forth in claim 1, wherein the cutter isrotatable relative to the catheter body about the longitudinal axis ofthe cutter.
 15. The tissue-removing catheter set forth in claim 14,further comprising a cutter driveshaft operatively connected to thecutter for imparting rotation of the cutter about the longitudinal axisof the cutter.
 16. The tissue-removing catheter set forth in claim 1,further comprising: a handle coupled to the proximal end of the catheterbody; and an actuator coupled to the handle, wherein the actuator isoperatively connected to the force-transmitting member and configured toimpart longitudinal movement of the force-transmitting member relativeto the catheter body.
 17. The tissue-removing catheter set forth inclaim 1, wherein the force-transmitting member comprises a sleevereceived above the catheter body.
 18. A method of removing tissue from abody lumen, the method comprising: inserting a tissue-removing catheterinto the body lumen, the tissue-removing catheter comprising an elongatecatheter body configured for insertion into the body lumen, the catheterbody having opposite distal and proximal ends, a longitudinal axisextending between the distal and proximal ends, a cutter locatedgenerally at the distal end of the catheter body adapted to removetissue from the body lumen, the cutter having a proximal end portion, adistal end portion, and a longitudinal axis extending between theproximal and distal end portions, a cutter housing adjacent the distalend of the catheter body, the cutter housing including a distallongitudinal portion located distal of the cutter, wherein the distallongitudinal portion is pivotable generally about a hinge axis, relativeto the cutter between a closed position, in which the cutter is coveredby the cutter housing, and an open position, in which at least a portionof the cutter is exposed, a force-transmitting member extending alongthe catheter body and being longitudinally movable relative to thecatheter body, wherein a distal end portion of the force-transmittingmember is operatively connected to the distal longitudinal portion ofthe cutter housing such that distal movement of the force-transmittingmember relative to the catheter body and the cutter imparts pivoting ofthe distal longitudinal portion of the cutter housing to its openposition to expose the cutter, and a track located adjacent the distalend of the catheter body, the track defining a slot having an offsetportion extending at an offset angle relative to the longitudinal axisof the catheter body, wherein the cutter housing is configured to trackalong the offset portion of the slot when the force-transmitting memberis moved distally relative to the catheter body; wherein the slot has ashape and the shape of the slot is the same when the cutter housing isin the open position and the closed position; moving, after saidinserting a tissue-removing catheter into the body lumen, theforce-transmitting member distally relative to the catheter body and thecutter to impart pivoting of the distal longitudinal portion of thecutter housing to its open position to expose the cutter; and removing,after said moving the force-transmitting member, tissue from the bodylumen using the cutter.
 19. The method of removing tissue from a bodylumen set forth in claim 18, wherein said removing tissue from the bodylumen using the cutter comprises rotating the cutter relative to thecatheter body.
 20. The method of removing tissue from a body lumen setforth in claim 18, further comprising moving, after said removing tissuefrom the body lumen using the cutter, the force-transmitting memberproximally relative to the catheter body and the cutter to impartpivoting of the distal longitudinal portion of the cutter housing to itsclosed position to cover the cutter.